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NCT00109707 · OUTCOME

Overall Survival (OS) (Phase II)

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies · Source last updated 2021-06-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to End of the Treatment (Approximately 7.5 years)

What was measured

OS was calculated for all participants as the time between the start of nilotinib and death. Participants were followed for survival after discontinuation, every 3 months, and were included in the analysis of OS. Censoring was at the date of the last contact for discontinued participants and followed up for survival.

Analysis population: Full Analysis Set (FAS): All participants who received at least one dose of study medication.

Groups in this outcome

CML-CP With Prior Imatinib Only

Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

CML-AP With Prior Imatinib Only

Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

CML-CP

Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
CML-CP With Prior Imatinib Only321
CML-AP With Prior Imatinib Only137
CML-CP49

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CML-CP With Prior Imatinib OnlyNANot reported77.93NAMedian OS was not reached as there were an insufficient number of participants
CML-AP With Prior Imatinib Only47.54Not reported38.2464.30Not reported
CML-CPNANot reportedNANAMedian OS was not reached as there were an insufficient number of participants
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median OS was not reached as there were an insufficient number of participants
        group Id
        OG000
        lower Limit
        77.93
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        38.24
        upper Limit
        64.30
        value
        47.54
      3. comment
        Median OS was not reached as there were an insufficient number of participants
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      49
    units
    Participants
description
OS was calculated for all participants as the time between the start of nilotinib and death. Participants were followed for survival after discontinuation, every 3 months, and were included in the analysis of OS. Censoring was at the date of the last contact for discontinued participants and followed up for survival.
dispersion Type
95% Confidence Interval
groups
  1. description
    Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    OG000
    title
    CML-CP With Prior Imatinib Only
  2. description
    Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    OG001
    title
    CML-AP With Prior Imatinib Only
  3. description
    Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    id
    OG002
    title
    CML-CP
param Type
MEDIAN
population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication.
reporting Status
POSTED
time Frame
Up to End of the Treatment (Approximately 7.5 years)
title
Overall Survival (OS) (Phase II)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice